FDA Reopens Comment Period on Gluten-Free Labeling Proposal

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Food agency announcement coincides with the anniversary of allergen law mandating standards for products consumed by individuals with celiac disease and others adhering to medically prescribed gluten-free diet.

Today, the FDA announced it was reopening the public comment period on its gluten-free labeling proposal mandated in a seven-year old allergen labeling law according to the American Celiac Disease Alliance (ACDA), the national advocacy organization representing patients, researchers, food manufacturers and others serving the celiac community.

Along with news about opening up the comment period, the agency released a safety assessment, analyzing the research on the amount of gluten that can safely be consumed by those who have celiac disease. The 60-day comment period for both the overall gluten-free labeling proposal and the safety assessment will run from the date FDA’s notice is published in the Federal Register. The docket number is FDA-2005-N-0404 and comments can be submitted by going to http://www.regulations.gov.

The FDA is allowing time for additional comments to ensure that it has the best scientific, evidence-based information to establish the country’s first ever standard for gluten-free products. The Food Allergen Labeling and Consumer Protection Act (FALCPA) directed the FDA to come up with a standard and the agency in 2007 proposed that gluten-free food contain less than 20 parts per million (ppm) of gluten. Action was to be completed the following year, instead the regulation then stalled.

Dr. Alessio Fasano of the University of Maryland’s Center for Celiac Research has authored research demonstrating a 20ppm would be safe. “This is a standard that has been in use in Europe for almost two decades, and the science supports the U.S. adopting it as well,” said Fasano.

Advocates, led by the ACDA, have been pressuring FDA for years to complete the gluten-free regulations. In May, hundreds from the celiac and gluten-free community rallied at the Gluten-Free Labeling Summit in Washington, DC. The event garnered nationwide attention as baking expert, and cookbook author, Jules Shepard, assisted by other gluten-free chefs, constructed the world’s largest gluten-free cake. Michael Taylor, FDA’s Deputy Commissioner for Food, attended providing assurance the agency was working hard to complete the gluten-free regulation.

FDA appears intent on getting the job done right and without further delays. “This is critically important since individuals with celiac disease and gluten-sensitivity have been left to fend for themselves, while companies place ‘gluten-free’ on products like water that never contained any of the forbidden grains – wheat, rye, or barley,” said ACDA President, Beth Hillson.

An estimated 3 million Americans have celiac disease, and possibly even more are thought to be gluten-sensitive. Both conditions require adherence to the medically prescribed gluten-free diet. In Italy, England, Australia, and elsewhere in the world, labeling standards have existed for decades. In the U.S., food manufacturers can claim “gluten-free” on product labels without taking any steps to ensure the ingredients they use are not cross contaminated with harmful levels of gluten.

Dr. Stefano Guandalini, Medical Director of the University of Chicago Celiac Disease Center notes, “Celiac disease is a serious, life-threatening medical condition. In this country, the food products that patients need to treat the condition are virtually unregulated leaving these individuals at risk of harm each and every day. It is inexcusable.”

The gluten-free market has changed dramatically since 2004, when product sales totaled $560 million. A year from now, those numbers are expected to reach $2.6 billion. Many companies are now using the gluten-free label to attract customers, but some do not follow the strict procedures needed to guarantee a product is truly gluten-free. Other manufacturers are reluctant to label their products “gluten-free” because there is no accepted standard.

Scott Mandell, CEO of Enjoy Life Foods states, “The absence of a standard has created substantial anxiety and confusion for those who must adhere to the gluten-free diet for medical reasons. Industry is looking forward to FDA taking the next step and finalizing this standard.”

About the American Celiac Disease Alliance (ACDA)
The non-profit American Celiac Disease Alliance was established in 2003 as the national advocacy organization for celiac disease in the United States. Unifying patient support groups, researchers, food manufacturers and others serving the community, the ACDA advances policy initiatives to improve the lives of those with celiac disease. The organization spearheaded the grassroots campaign that was instrumental to the passage FALCPA.

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Andrea Levario

Beth Hillson
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American Celiac Disease Alliance